CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject areas to further instruct the public about the many ways CDER protects and promotes public health.

For more information go to https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education

Belize began registering medicines as a result of the Food and Drugs (Registration, Licensing and Inspection) Regulations passed in 2017,  and the products that are listed are new to the country. Previously imported medicines that were available in the market prior to the new regulations were grandfathered into the system while ensuring its safety, efficacy and quality. The publication of a list of registered medicines is a best practice in transparency and accountability of regulatory systems as recommended by PAHO/WHO. Among the many benefits, it helps to provide the public and other stakeholders with visibility over what is legally approved to be sold in the market. Other countries in the CARICOM block can look to Belize as an important leader in this area.

For more information go to: http://health.gov.bz/www/units/drug-inspectorate-unit/drug-registration/989-new-drugs-registered-2017-2019

CARPHA’s Caribbean Regulatory System (CRS) recently recommended its 40th medicine to CARICOM governments. “This is an important milestone for the CRS because it shows that manufacturers are increasingly using the system and it can work” said Dr. Virginia Asin, who oversees the program as the Director, Surveillance, Disease Prevention and Control at CARPHA. The updated list of recommended medicines is publicly available on CARPHA’s webpage. 

The CRS assists the small states of CARICOM with the resource- and time-intensive task of evaluating medicines for safety, quality, and efficacy. Its approach requires that all medicines reviewed are already approved by a PAHO-designated reference authority, the European Union, or WHO Prequalification program. Once confirmed as eligible, the medicines intended for the CARICOM markets are verified as the same. Internal data show that the medicines available in highly regulated markets are not necessarily the same products that are sold in CARICOM.

This year, World Blood Donor Day will once again be celebrated around the world on 14 June. The event serves to thank voluntary, unpaid blood donors for their life-saving gifts of blood and also to raise awareness of the need for regular blood donations to ensure that all individuals and communities have access to affordable and timely supplies of safe and quality-assured blood and blood products, as an integral part of universal health coverage and a key component of effective health systems.

Focus of this year’s campaign

The theme of this year’s campaign is blood donation and universal access to safe blood transfusion, as a component of achieving universal health coverage. We have developed the slogan “Safe blood for all” to raise awareness of the universal need for safe blood in the delivery of health care and the crucial roles that voluntary donations play in achieving the goal of universal health.

Host for World Blood Donor Day 2019

• The host country for World Blood Donor Day 2019 is Rwanda. The global event will be held in Kigali, Rwanda on 14 June 2019.
• The host for the Region of the Americas event will be Costar Rica.

For more information go to https://www.paho.org/hq/index.php?option=com_content&view=article&id=15148:safe-blood-for-all-14-june-2019&Itemid=39594&lang=en

Despite considerable progress, the Pan American Health Organization (PAHO) estimates that 30% of the population of the Americas still do not have access to the health care they need because of multifaceted barriers. On April 9, leaders, including Mexico’s President Andrés Manuel López Obrador, PAHO director Carissa Etienne, and UN High Commissioner for Human Rights Michelle Bachelet, gathered with academics, activists, and representatives of social movements in Mexico City to hear the report of the Commission on Universal Health in the 21st Century (…) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30864-5/fulltext

Recently, the CARPHA/CRS recommended Gilead’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg) film-coated tablet for the treatment of Hepatitis C.

The product is the first combination of its kind, and is listed on the WHO Essential Medicine List. It is also a first line therapy as recommended by WHO. The rationale for such an important status is that Epclusa is curative for all genotypes of Hepatitis C. If not treated, Hepatitis C can lead to negative health outcomes like liver failure and cancer.

This is a significant development for patients in CARICOM because there are estimated to be perhaps 100,000 cases of Hepatitis C in the region, but few authorized treatments. Epclusa, for example, does not have marketing authorization in any CARICOM state. It is also significant for public health. Cures such as this one are critical to strategies to eliminate Hepatitis C in the Americas.

Patients need access to these innovative therapies quickly, and major manufacturers are increasingly using the CRS because of the efficiencies it brings in speeding access to medicines. The CARPHA/CRS pools CARICOM markets together and offers a single portal of entry to the region’s 17 million people with one set of internationally recognized standards, and accelerated and transparent timelines. It is a major improvement over the current status quo in regulation of medicines, where products can take years to receive approval in the different national systems of CARICOM.

The list of recommended products is growing by the month and can be found here.

 For more information go to http://carpha.org/what-we-do/laboratory-services-and-networks/crs

Check out the latest news from PAHO Health Systems and Services Department and get to know our projects and advances toward universal access to health and universal health coverage in the Region of the Americas.

https://us4.campaign-archive.com/?u=487855692ac2aa91b795e38af&id=f6a372a683

Prohibition became effective as of January 1, 2019. Measure is the result of the Minamata convention.

The manufacture, importation and commercialization of thermometers and pressure meters that use a column of mercury for health diagnosis is prohibited. The measure also includes a ban on the use of such equipment in health services, which will have to dispose of the solid waste containing mercury, according to the norms defined by Anvisa (Resolution of the Collegiate Board of Directors – RDC 306/2004) and Environmental Bodies (Federal and State ).

The measure was defined by the Resolution of Collegiate Board of Directors – RDC 145/2017, and entered into force on Tuesday (1/1). The prohibition of thermometers and sphygmomanometers, as technically called mercury column pressure meters, is a result of the Minamata Convention. The convention was signed by Brazil and 140 countries in 2013 and aims to eliminate the use of mercury in different products such as batteries, lamps and health equipment, among others.

For more information go to ANVISA

The Caribbean Regulatory System (CRS) recently recommended its first non-communicable disease (NCD) medicines, including amlodipine for high blood pressure and anastrozole for breast cancer. The Caribbean is the worst affected sub-region in the Americas for NCDs, which are a leading cause of premature mortality, making up about half of all deaths of people under 70.

The recommended medicines are some of the most important tools that health providers and patients have to correct dangerous conditions like high blood pressure and cancer. For example, amlodipine is recognized as a critically effective blood pressure lowering medicine and is one of the most highly purchased products in the sub-region. Anastrozole is a key treatment in breast cancer and is listed on the World Health Organization’s (WHO) list of essential medicines.

Commenting on the development Dr. Virginia Asin-Oostburg, Director of Surveillance, Disease Prevention and Control at CARPHA who manages the CRS programme said, “This marks an important new milestone for assuring quality NCD medicines in the region, where we know regulatory capacity can be limited due to small populations and few human resources.“  She further noted that each medicine has to be pre-approved by a strong regulatory authority like the United States Food and Drug Administration or the World Health Organization, and be suitable for the Region, before it can be recommended by the CRS to CARICOM member states.

There are more NCD medicines under review at the CRS, and a goal of the program is to have recommended quality versions of all NCD medicines listed on WHO’s list of essential medicines.

Source: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS